Design and ISO 9001

This has to be one of the terms that is often misunderstood. Design applies to a quality management system where you invent something from the beginning, or come up with a solution to the requirements that your customer has. It doesn't apply in all systems: for example, many manufacturing businesses make the same products over and over, and many service businesses provide the same services repeatedly.

The Standard has built-in allowances for things that do not apply in your system. You do this when you identify the Scope of your system, and you can designate certain clauses - such as the one for Design - as not applicable if that requirement cannot be applied to your quality management system.

But you must provide reasonable justification for it not applying, and doing so must not affect your ability or responsibility to provide product/services that meet requirements, both those of your customer and any applicable regulatory or statutory ones.

Consider a commercial cleaning company, who cleans offices and other commercial premises: the same service, although in different premises. They could specify the design clause (8.3) as not applicable because they simply don't do any.

Note that you can't just choose to opt out from a clause because you prefer not to do it. For example, an architectural practice could not exclude 'design' from their business activities, since it's fundamental to what they do. A business that repairs products sold under warranty, which they repair at their own premises, could not claim exemption from 8.5.3 'property belonging to customers or external providers' because it most certainly applies.

Your certifier has to agree if you decide that certain clauses do not apply, and agree with your reasons. Generally, this is done before certification audit, but it can also be discussed with your auditor.